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Adverse Occurrence type:
In Sweden, over 14 year period, approximately 5 HCV window period cases detected of 5,240,000 donations screened with serology (approximately 1 in a million). Given 1.5 units produced per donation, risk estimated 1.5 per million or 1 per 666,667 units transfused.
Time to detection:
29 days after transfusion, HCV NAT and HCV core antigen detected in plasma screened by fractionation manufacturer. 35 days after transfusion, recipient found positive by HCV NAT. Virus sequencing from donor and recipient 99.8% identical. Donor had undetectable RNA 153 days after donation, but recipient continued to be viremic.
Alerting signals, symptoms, evidence of occurrence:
Plasma fractionation manufacturer detected HCV infection. Donor (presumably infected by needlestick) and recipient (9 day old infant) asymptomatic.
Demonstration of imputability or root cause:
Donor had accidental needle stick 2-3 weeks prior to donation. HCV serology alone for screening did not detect window period infection. NAT not routinely used for screening in Sweden.
Waldenstrom J, et al. Neonatal transfusion-transmitted hepatitis C virus infection following a pre-seroconversion window-phase donation in Sweden. Scand J Infect Dis. 45(10):796-9, 2013 Oct.
Expert comments for publication:
This article well describes risk of window period infections from HCV in blood transfusion for Sweden. Also noted is the benefit of additional screening done by plasma fractionation manufacturers.